drugset / Trial / NCT05537051

A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours

NCT05537051 ↗

Phase 1 Unknown 30 enrolled BioNTech SE
NaSequentialOpen-labelTreatment

Summary

The purpose of this research is to assess the safety, tolerability and effectiveness of PM1021 Monotherapy and PM1021 in Combination with PM8001 in Patients with Advanced Solid Tumours. In this study, up to 30 patients will be enrolled in Australia only. Advanced solid cancers are associated with poor prognosis and pose a significant challenge for treatment strategies. Effective treatments for advanced metastatic malignancies that have failed available standard of care treatment represent a major unmet medical need. Biotheus Inc. is developing PM1021, a monoclonal anti-T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibody (IgG1) and PM8001 (a PD-L1/TGF-beta bispecific Fc fusion protein) as treatment for advanced solid tumours.

Timeline

Start
2023-10-30
Primary completion
2024-10-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PM1021 Monoclonal antibody 150 mg —
Subject PM1021 Monoclonal antibody 450 mg —
Subject PM1021 Monoclonal antibody 900 mg —
Subject PM1021 Monoclonal antibody 1200 mg —
Subject PM8001 Protein / enzyme biologic 20 mg/kg —

Indications